GLP Study Inspection and Audit Team Lead​

What You Will Achieve

The role leads a multi-site based team of qualified GLP Study, Vendor and Process auditors, responsible for executing both study inspection and audits, ensuing that Pfizer quality standards are consistently applied across all GLP programs. Through the oversight and execution of GLP study inspection and audit programs, the role accesses compliance with Pfizer Standard Operating Procedures (SOPs), policies, and applicable GLP worldwide regulations and guidelines (e.g. US FDA, UK MHRA and EU Directives). The lead is responsible for the delivery and execution of the Quality Assurance Unit (QAU) program activities across all GxP portfolio/programs/entities. The Team Lead is responsible for defining, executing and overseeing both the study inspection and audit strategies relevant to GLP Study, Vendor and Process portfolio / programs / entities.
 

This role also leads cross functional RQA projects and may be required to direct programmatic elements (such as risk assessments).

How You Will Achieve It

In this role, you will:

• Responsible for the design and execution of a comprehensive robust GLP study inspection, vendor and process oversight audit program including execution of the multiple GLP audit types across the enterprise (multiple GLP sites) and externally.
• Accountable for the communication of the GLP study, vendor and process audit strategies and outcomes across multiple Clinical and GLP stakeholders, supporting the broader quality assurance strategy for GLP Processes
• Directs and develops a team of highly skilled and multi-site audit colleagues who are responsible for leading and participating in Quality Assurance audits and performing Quality Assurance Unit activities for all GLP studies.
• Ensures a comprehensive risk assessment strategy for GLP study, vendor and process audits.
• Ensures GLP study, vendor and process audit outcomes are calibrated and driven to completion, ensures issues are escalated, and ensures holistic remediation plans and sustainability of CAPA
• Engages multiple GLP stakeholders in assuring risk factors are identified and communicated during all phases of the audit process
• Acts as a leader in RQA by continuously improving audit practices, sharing knowledge with counterparts and ensuring colleagues are adequately skilled and trained to meet the needs of the business
• Challenges, develops and provides feedback on key risks to RQA leadership and business process owners/program owners on a consistent basis

Here Is What You Need (Basic Qualifications)

• BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent
• 10+ years relevant experience (robust experience in auditing or quality management)
• 5+ years in a management role preferred (or equivalent) with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities
• Must be future oriented; Ability to anticipate future trends in vendor oversight and audit approach and develop strategy to evolve Pfizer’s practices accordingly
• Demonstrated ability to engage with and influence stakeholders through times of significant change
• Ability to identify key risks, need for escalation and ability to identify correct path for stakeholder engagement
• Demonstrates enhanced critical thinking capabilities
• Defines continuous improvement strategy and operational improvement opportunities to remove roadblocks
• Ability to lead a team and develop colleagues for continued growth
• Defines continuous improvement strategy and operational improvement opportunities to remove roadblocks
• Ability to communicate and influence at senior director or VP level
• Has SME capabilities and can represent Pfizer in industry conferences and with stakeholders
• Experience evaluating, sharing guidance and implementing improves on GLP quality standards or their application
• Able to use Digital technology to recognize and interpret business trends
• Continually accesses performance of team and holds team accountable for internal KPIs
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Bonus Points If You Have (Preferred Qualifications)

• Master’s or advanced degree preferred
• Experience leading GLP audit teams
• Experience growing and developing talent

OTHER INFORMATION

• The travel requirement may be up to 20%

The annual base salary for this position ranges f